Ferric Maltol (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE.
Routes of administration: ORAL.
Brand Names
- ACCRUFER
Indications and Usage
ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
Contraindications
ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients [see Description ( 11)] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. Hemochromatosis and other iron overload syndromes [see Warnings and Precautions ( 5.1)] . Use may result in iron overdose [see Overdosage ( 10)]. Receiving repeated blood transfusions. Use may result in iron overload [see Warnings and Precautions ( 5.2) and Overdosage ( 10)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Inflammatory Bowel Disease Flare [see Warnings and Precautions ( 5.1)] Iron Overload [see Warnings and Precautions ( 5.2)]
Overdosage
No data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea. In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity. Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation. Do not administer ACCRUFER to patients with iron overload [ see Contraindications ( 4) ]. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.